Clinical Study Schedule of Activities
1.0.0 - trial-use

Clinical Study Schedule of Activities, published by HL7 International - Biomedical Research & Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/Vulcan-schedule-ig/ and changes regularly. See the Directory of published versions

## : H2Q-MC-LZZT Research Study - XML Representation

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    <ResearchStudy xmlns="http://hl7.org/fhir">
      <id value="H2Q-MC-LZZT-ResearchStudy"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa"/>
      </meta>
      <text>
        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ResearchStudy</b><a name="H2Q-MC-LZZT-ResearchStudy"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ResearchStudy &quot;H2Q-MC-LZZT-ResearchStudy&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ResearchStudySoa.html">ResearchStudySoa</a></p></div><p><b>identifier</b>: id: H2Q-MC-LZZT (use: USUAL), id: NCTA12313212 (use: OFFICIAL), id: 60809</p><p><b>title</b>: Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease</p><p><b>protocol</b>: <a href="PlanDefinition-H2Q-MC-LZZT-ProtocolDesign.html">PlanDefinition/H2Q-MC-LZZT-ProtocolDesign</a></p><p><b>status</b>: completed</p><p><b>primaryPurposeType</b>: Treatment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-research-study-prim-purp-type.html">ResearchStudyPrimaryPurposeType</a>#treatment)</span></p><p><b>phase</b>: Phase 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-research-study-phase.html">ResearchStudyPhase</a>#phase-3)</span></p><p><b>category</b>: Interventional Study <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (ncimeta.nci.nih.gov#C98388)</span>, Randomized Clinical Trial <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (ncimeta.nci.nih.gov#C15417)</span>, Double Blind Study <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (ncimeta.nci.nih.gov#C15228)</span>, Placebo Control <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (ncimeta.nci.nih.gov#C49648)</span>, Parallel Study <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (ncimeta.nci.nih.gov#C82639)</span></p><p><b>focus</b>: Xanomeline <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (ncimeta.nci.nih.gov#C152926)</span>, Transdermal Patch Dosage Form <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (ncimeta.nci.nih.gov#C149996)</span>, PUBMED#9109749 Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>condition</b>: Alzheimer's Disease (Disorder) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#26929004)</span></p><p><b>contact</b>: Bob James, Ph.D.: ph: 555-555-5555(WORK)</p><h3>RelatedArtifacts</h3><table class="grid"><tr><td>-</td><td><b>Type</b></td><td><b>Label</b></td><td><b>Display</b></td><td><b>Citation</b></td><td><b>Url</b></td></tr><tr><td>*</td><td>documentation</td><td>Arch Neurol.1997;54(4):465-473</td><td>Arch Neurol.1997;54(4):465-473</td><td>Bodick NC, Offen WW, Levey AI, et al. Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease. Arch Neurol. 1997;54(4):465-473. doi:10.1001/archneur.1997.00550160091022</td><td> </td></tr><tr><td>*</td><td>documentation</td><td>Protocol H2Q-MC-LZZT(c)</td><td> </td><td> </td><td><a href="https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf">https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf</a></td></tr></table><p><b>keyword</b>: Selective M1 muscarinic agonists <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html">Medical Subject Headings</a>#D018721)</span>, Alzheimer Disease <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html">Medical Subject Headings</a>#D000544)</span>, Selective M1 muscarinic agonists <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html">Medical Subject Headings</a>#D018721)</span></p><p><b>description</b>: ## Xanomeline (LY246708)
    ### Protocol H2Q-MC-LZZT(c)
    Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease</p><p><b>sponsor</b>: <a href="Organization-EliLillyAndCompany.html">Organization/EliLillyAndCompany</a></p><p><b>principalInvestigator</b>: <a href="Practitioner-SamGetWell.html">Practitioner/SamGetWell</a> &quot; HOME&quot;</p><p><b>reasonStopped</b>: Accrual Goal Met <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-research-study-reason-stopped.html">ResearchStudyReasonStopped</a>#accrual-goal-met)</span></p><blockquote><p><b>arm</b></p><p><b>name</b>: Placebo</p><p><b>type</b>: C49648 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (ncimeta.nci.nih.gov#C49648)</span></p><p><b>description</b>: Placebo arm</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: Low-dose xanomeline arm</p><p><b>type</b>: C174266 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (ncimeta.nci.nih.gov#C174266)</span></p><p><b>description</b>: Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: High-dose xanomeline arm</p><p><b>type</b>: C174266 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (ncimeta.nci.nih.gov#C174266)</span></p><p><b>description</b>: High-dose xanomeline arm (75 cm2 TTS Formulation E, 81 mg xanomeline)</p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To determine if there is a statistically significant relationship (overall Type 1 error rate, α=.05) between the change in both ADAS-Cog and CIBIC scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg]).</p><p><b>type</b>: Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#primary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To document the safety profile of the xanomeline TTS.</p><p><b>type</b>: Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#primary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas.</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas.</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer’s Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment.</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the treatment response as a function of Apo E genotype.</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote></div>
      </text>
      <identifier>
        <use value="usual"/>
        <value value="H2Q-MC-LZZT"/>
      </identifier>
      <identifier>
        <use value="official"/>
        <system value="https://clinicaltrials.gov/show/"/>
        <value value="NCTA12313212"/>
      </identifier>
      <identifier>
        <value value="60809"/>
      </identifier>
      <title
             value="Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease"/>
      <protocol>
        <reference value="PlanDefinition/H2Q-MC-LZZT-ProtocolDesign"/>
      </protocol>
      <status value="completed"/>
      <primaryPurposeType>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"/>
          <code value="treatment"/>
        </coding>
      </primaryPurposeType>
      <phase>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
          <code value="phase-3"/>
        </coding>
      </phase>
      <category>
        <coding>
          <system value="http://ncimeta.nci.nih.gov"/>
          <code value="C98388"/>
          <display value="Interventional Study"/>
        </coding>
      </category>
      <category>
        <coding>
          <system value="http://ncimeta.nci.nih.gov"/>
          <code value="C15417"/>
          <display value="Randomized Clinical Trial"/>
        </coding>
      </category>
      <category>
        <coding>
          <system value="http://ncimeta.nci.nih.gov"/>
          <code value="C15228"/>
          <display value="Double Blind Study"/>
        </coding>
      </category>
      <category>
        <coding>
          <system value="http://ncimeta.nci.nih.gov"/>
          <code value="C49648"/>
          <display value="Placebo Control"/>
        </coding>
      </category>
      <category>
        <coding>
          <system value="http://ncimeta.nci.nih.gov"/>
          <code value="C82639"/>
          <display value="Parallel Study"/>
        </coding>
      </category>
      <focus>
        <coding>
          <system value="http://ncimeta.nci.nih.gov"/>
          <code value="C152926"/>
          <display value="Xanomeline"/>
        </coding>
      </focus>
      <focus>
        <coding>
          <system value="http://ncimeta.nci.nih.gov"/>
          <code value="C149996"/>
          <display value="Transdermal Patch Dosage Form"/>
        </coding>
      </focus>
      <focus>
        <text
              value="PUBMED#9109749 Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease"/>
      </focus>
      <condition>
        <coding>
          <system value="http://snomed.info/sct"/>
          <code value="26929004"/>
          <display value="Alzheimer's Disease (Disorder)"/>
        </coding>
      </condition>
      <contact>
        <name value="Bob James, Ph.D."/>
        <telecom>
          <system value="phone"/>
          <value value="555-555-5555"/>
          <use value="work"/>
        </telecom>
      </contact>
      <relatedArtifact>
        <type value="documentation"/>
        <label value="Arch Neurol.1997;54(4):465-473"/>
        <display value="Arch Neurol.1997;54(4):465-473"/>
        <citation
                  value="Bodick NC, Offen WW, Levey AI, et al. Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease. Arch Neurol. 1997;54(4):465-473. doi:10.1001/archneur.1997.00550160091022"/>
      </relatedArtifact>
      <relatedArtifact>
        <type value="documentation"/>
        <label value="Protocol H2Q-MC-LZZT(c)"/>
        <url
             value="https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf"/>
      </relatedArtifact>
      <keyword>
        <coding>
          <system value="https://www.nlm.nih.gov/mesh"/>
          <code value="D018721"/>
        </coding>
        <text value="Selective M1 muscarinic agonists"/>
      </keyword>
      <keyword>
        <coding>
          <system value="https://www.nlm.nih.gov/mesh"/>
          <code value="D000544"/>
        </coding>
        <text value="Alzheimer Disease"/>
      </keyword>
      <keyword>
        <coding>
          <system value="https://www.nlm.nih.gov/mesh"/>
          <code value="D018721"/>
        </coding>
        <text value="Selective M1 muscarinic agonists"/>
      </keyword>
      <description
                   value="## Xanomeline (LY246708)
    ### Protocol H2Q-MC-LZZT(c)
    Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease"/>
      <sponsor>
        <reference value="Organization/EliLillyAndCompany"/>
      </sponsor>
      <principalInvestigator>
        <reference value="Practitioner/SamGetWell"/>
      </principalInvestigator>
      <reasonStopped>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/research-study-reason-stopped"/>
          <code value="accrual-goal-met"/>
        </coding>
      </reasonStopped>
      <arm>
        <name value="Placebo"/>
        <type>
          <coding>
            <system value="http://ncimeta.nci.nih.gov"/>
            <code value="C49648"/>
          </coding>
        </type>
        <description value="Placebo arm"/>
      </arm>
      <arm>
        <name value="Low-dose xanomeline arm"/>
        <type>
          <coding>
            <system value="http://ncimeta.nci.nih.gov"/>
            <code value="C174266"/>
          </coding>
        </type>
        <description
                     value="Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)"/>
      </arm>
      <arm>
        <name value="High-dose xanomeline arm"/>
        <type>
          <coding>
            <system value="http://ncimeta.nci.nih.gov"/>
            <code value="C174266"/>
          </coding>
        </type>
        <description
                     value="High-dose xanomeline arm (75 cm2 TTS Formulation E, 81 mg xanomeline)"/>
      </arm>
      <objective>
        <name
              value="To determine if there is a statistically significant relationship (overall Type 1 error rate, α=.05) between the change in both ADAS-Cog and CIBIC scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg])."/>
        <type>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
            <code value="primary"/>
          </coding>
        </type>
      </objective>
      <objective>
        <name value="To document the safety profile of the xanomeline TTS."/>
        <type>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
            <code value="primary"/>
          </coding>
        </type>
      </objective>
      <objective>
        <name
              value="To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas."/>
        <type>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
            <code value="secondary"/>
          </coding>
        </type>
      </objective>
      <objective>
        <name
              value="To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas."/>
        <type>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
            <code value="secondary"/>
          </coding>
        </type>
      </objective>
      <objective>
        <name
              value="To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer’s Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment."/>
        <type>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
            <code value="secondary"/>
          </coding>
        </type>
      </objective>
      <objective>
        <name
              value="To assess the treatment response as a function of Apo E genotype."/>
        <type>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
            <code value="secondary"/>
          </coding>
        </type>
      </objective>
    </ResearchStudy>